STOCKERT SCP RHYTHM

K042374 · Stockert Instrumente GmbH · DWA · Sep 23, 2004 · Cardiovascular

Device Facts

• Record ID: K042374
• Device Name: STOCKERT SCP RHYTHM
• Applicant: Stockert Instrumente GmbH
• Product Code: DWA · Cardiovascular
• Decision Date: Sep 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4380
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stockert SCP Rhythm is an accessory to the S3 Cardiopulmonary Bypass Console that allows for cyclically controlled delivery of blood with the Stöckert SCP during cardiopulmonary bypass for periods of up to six hours.

Device Story

Stöckert SCP Rhythm is a modified version of the S3 Cyclic RPM Control Module; functions as an accessory to the S3 Cardiopulmonary Bypass Console. Device provides cyclically controlled blood delivery during cardiopulmonary bypass procedures. Modifications from predicate include updated display panel artwork and firmware/software changes; hardware and electronics remain unchanged. Used in clinical settings during bypass surgery; operated by perfusionists or clinical staff. Output consists of controlled pump speed cycles to manage blood flow. Benefits include precise control of blood delivery during bypass for up to six hours.

Clinical Evidence

Bench testing only; no clinical data provided. Verification and validation of firmware/software modifications performed to demonstrate substantial equivalence.

Technological Characteristics

Accessory to S3 Cardiopulmonary Bypass Console; firmware/software-controlled pump speed regulation. No hardware or electronic modifications from predicate. Sterilization and material specifications not detailed beyond reference to existing S3 console components.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass requiring cyclically controlled blood delivery via the Stöckert SCP system for up to six hours.

Regulatory Classification

Identification

A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.

Predicate Devices

• Stöckert S3 Cyclic RPM Control Module (K971520)

Submission Summary (Full Text)

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### SEP 2 3 2004

# 04237

## Special 510(k): Device Modification 510(k) Summary for Stöckert SCP Rhythm

#### 1. SPONSOR

Stöckert Instrumente GmbH Lindberghstrasse 25 80939 Munich Germany

Helmut Hofl, Director, Quality Assurance and Regulatory Affairs Contact: Telephone: [phone] 011 49 89 323 01100 Facsimile:

Date Prepared: August 31, 2004

#### 2. DEVICE NAME

Stöckert SCP Rhythm Proprietary Name: Common/Usual Name: Cyclic RPM Control Accessory to cardiopulmonary bypass console Classification Name:

#### 3. PREDICATE DEVICE

Stöckert S3 Cyclic RPM Control Module (K971520)

#### 4. DEVICE DESCRIPTION

The Stöckert SCP Rhythm is a modification of the S3 Cyclic RPM Control Module. The modifications consist of two changes: ( 1 ) a change to the artwork of the display panel to show SCP Rhythm rather than Cyclic RPM Control and (2) firmware and software modifications. No modifications are being made to the hardware or electronics of any of the components. The Stöckert SCP Rhythm is intended for use with the SCP System as mounted on an S3 Cardiopulmonary Bypass Console.

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#### న. INTENDED USE

The Stockert SCP Rhythm is an accessory to the S3 Cardiopulmonary Bypass Console that allows for cyclically controlled delivery of blood with the Stöckert SCP during cardiopulmonary bypass for periods of up to six hours.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The proposed Stöckert SCP Rhythm is identical in intended use and fundamental scientific technology to the parent Stöckert S3 Cyclic RPM Control. The differences between the proposed and parent device are limited to the display panel and firmware/software. Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k), that the Stöckert SCP Rhythm complies with specifications, meets user requirements, and the differences between the parent and the proposed device do not raise new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

SEP 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Device Consultants, Inc. c/o Ms. Rosina Robinson Senior Staff Consultant 49 Plain Street North Attleborn, MA 02760

Re: K042374 Stöckett SCP Rhythm Regulation Number: 21 CFR 870.9380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: Class II (two) Product Code: DWA Dated: August 31, 2004 Received: September 1, 2004

Dear Ms. Robinson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosule) to trgans actment date of the Medical Device Amendments, or to commerce pror to thay 2017 3, in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains of the Act include requirements for annual registration, listing of general controlly proficions or actice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a00 rols. Existing major regulations affecting your device can may be subject to back adder and Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Rosina Robinson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

onner R. Vochner

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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): Ko 42 3 7 4

Device Name: Stöckert SCP Rhythm

Indications for Use:

The Stöckert SCP Rhythm is an accessory to the S3 Cardiopulmonary Bypass Console that allows for cyclically controlled delivery of blood with the Stöckert SCP during cardiopulmonary bypass for periods of up to six hours.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Wchines

(Division Sign-Off) (Division Sign-on)
Division of Cardiovascular Devices

510(K) Number Kodz 274